Submission QC Automation

Integrating seamlessly with your existing workflows, Freyr’s Submission QC Automation uses AI-driven validation and error detection, empowering teams to achieve flawless Regulatory submissions with minimal manual intervention.

Submission QC Automation - Overview

Submission QC Automation utilizes advanced automation technologies to improve the quality control of Regulatory submission documents. This service encompasses a comprehensive automated check suite that ensures documents meet Regulatory requirements before submission.

Key features include:

  • Automated Quality Checks: The service employs sophisticated algorithms to perform real-time assessments of submission documents, identifying potential errors or compliance issues.
  • Document Validation: Automated validation processes ensure that all necessary metadata, file formats, and document structures conform to Regulatory standards.
  • Error Reporting: The system generates detailed reports on identified issues, allowing teams to address problems proactively and efficiently.
  • Integration with Existing Workflows: Submission QC Automation seamlessly integrates with existing document management systems and submission workflows, ensuring minimal disruption to current processes.

Submission QC Automation

Freyr brings a wealth of expertise in Regulatory Affairs and quality control automation. Our team consists of professionals with extensive backgrounds in Regulatory compliance, document management, and automation technologies. Areas of expertise include:

  • In-depth understanding of global Regulatory frameworks, including eCTD requirements, ensures that our automation processes align with industry standards
  • Expertise in implementing Robotic Process Automation (RPA), Machine Learning (ML), and Natural Language Processing (NLP) to enhance quality control measures
  • Proven record of working with clients across various sectors, including Pharmaceuticals, Biologics, and Medical Devices, allowing us to tailor our solutions to meet specific industry needs
Submission QC Automation

The Submission QC Automation service offers numerous benefits to organizations looking to optimize their Regulatory submission processes:

  • Automating quality checks significantly reduces the risk of human error, ensuring that submissions are accurate and compliant
  • By streamlining the quality control process, organizations can reduce the time spent on manual reviews and corrections, allowing for faster submission timelines
  • Minimizing manual intervention leads to lower operational costs, freeing up resources for more strategic initiatives
  • Automated checks ensure that all documents meet Regulatory requirements, reducing the risk of submission rejections or delays
  • Scalability, designed to accommodate varying submission volumes, making it suitable for organizations of all sizes, from startups to large multinational corporations
Submission QC Automation

Celebrating Customers Success

 

Medicinal Products

Publishing and Submission

UK

We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.

Please keep up the great work as we have many milestones to achieve over the next year.

Ed Venkat

Global CMC Technical Lead

 

Medicinal Products

Publishing and Submission

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Michael Bellero

Sr. Director, Head of Regulatory Operations

 

Medical Devices

Publishing and Submission​

USA

Communication and on the ground knowledge or RA requirements - this has been our experience for India. Quick to response and willing to have calls to explain requirements. Very happy with the RA work conducted in India, would use for other markets. We are satisfied. ​

Director of Regulatory Affairs​

France-based, Leading Global Supplier of Women Healthcare Products Company​